Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Stage I melanoma is defined by the following clinical stage groupings:

• T1a, N0, M0
• T1b, N0, M0
• T2a, N0, M0

Standard treatment options:

• Current evidence suggests that lesions 2 mm or less in thickness may be treated conservatively with radial excision margins of 1 cm. A randomized trial compared narrow margins (1 cm) with wide margins (at least 3 cm) in patients with melanomas no thicker than 2 mm.[1,2] No difference was observed between the two groups in respect to the development of metastatic disease, disease-free survival, or overall survival (OS). Two other randomized trials have compared 2 cm margins with wider margins (i.e., 4 cm or 5 cm), and found no statistically significant difference in local recurrence, distant metastasis, or OS, with a median follow-up of 10 years or more for both trials.[3-5][Level of evidence:1iiA] In the Intergroup Melanoma Surgical Trial, the reduction in margins from 4 cm to 2 cm was associated with a statistically significant reduction in the need for skin grafting (from 46% to 11%, P < .001) and a reduction in the length of the hospital stay.[5] Depending on the location of the melanoma, most patients can now have this procedure performed on an outpatient basis.

  Elective regional lymph node dissection is of no proven benefit for patients with stage I melanoma. Lymphatic mapping and sentinel lymph node biopsy for patients who have tumors of intermediate thickness and/or ulcerated tumors, however, may allow the identification of individuals with occult nodal disease who might benefit from regional lymphadenectomy and adjuvant therapy.[6-9] The International Multicenter Selective Lymphadenectomy Trial (MSLT-1) demonstrated that lymphatic mapping and sentinel lymph node biopsy can be performed safely (10.1% minor complications' rate) and with a low false-negative rate (5.2%).[10] However, this rate was only obtained after a surgical experience of 55 cases (i.e., 30 cases to enter the trial and 25 cases during the trial). Full publication of the survival data from this study is pending.

Treatment options under clinical evaluation:

• Because of the higher rate of treatment failure in the subset of clinical stage I patients with occult nodal disease, clinical trials are evaluating new techniques to detect submicroscopic sentinel lymph node metastasis to identify those patients who may benefit from regional lymphadenectomy with or without adjuvant therapy. One of the objectives of the currently ongoing phase III Sunbelt Melanoma Trial (UAB-9735) is to determine the effects of lymphadenectomy with or without adjuvant high-dose interferon-alpha-2b versus observation on disease-free survival and OS in patients with submicroscopic sentinel lymph node metastasis detected only by the polymerase chain reaction (PCR) (i.e., sentinel lymph node negative by histology and immunohistochemistry). No survival data have been reported from this study. An ongoing diagnostic study (UCCRC-9308) is testing the combination of reverse transcription and PCR in the detection of melanoma tumor antigen transcripts in lymph nodes and peripheral blood samples. Information about ongoing clinical trials is available from the NCI Web site.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage I melanoma. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Veronesi U, Cascinelli N: Narrow excision (1-cm margin). A safe procedure for thin cutaneous melanoma. Arch Surg 126 (4): 438-41, 1991.  [PUBMED Abstract]
   
   
2. Veronesi U, Cascinelli N, Adamus J, et al.: Thin stage I primary cutaneous malignant melanoma. Comparison of excision with margins of 1 or 3 cm. N Engl J Med 318 (18): 1159-62, 1988.  [PUBMED Abstract]
   
   
3. Cohn-Cedermark G, Rutqvist LE, Andersson R, et al.: Long term results of a randomized study by the Swedish Melanoma Study Group on 2-cm versus 5-cm resection margins for patients with cutaneous melanoma with a tumor thickness of 0.8-2.0 mm. Cancer 89 (7): 1495-501, 2000.  [PUBMED Abstract]
   
   
4. Balch CM, Soong SJ, Smith T, et al.: Long-term results of a prospective surgical trial comparing 2 cm vs. 4 cm excision margins for 740 patients with 1-4 mm melanomas. Ann Surg Oncol 8 (2): 101-8, 2001.  [PUBMED Abstract]
   
   
5. Balch CM, Urist MM, Karakousis CP, et al.: Efficacy of 2-cm surgical margins for intermediate-thickness melanomas (1 to 4 mm). Results of a multi-institutional randomized surgical trial. Ann Surg 218 (3): 262-7; discussion 267-9, 1993.  [PUBMED Abstract]
   
   
6. Hochwald SN, Coit DG: Role of elective lymph node dissection in melanoma. Semin Surg Oncol 14 (4): 276-82, 1998.  [PUBMED Abstract]
   
   
7. Essner R, Conforti A, Kelley MC, et al.: Efficacy of lymphatic mapping, sentinel lymphadenectomy, and selective complete lymph node dissection as a therapeutic procedure for early-stage melanoma. Ann Surg Oncol 6 (5): 442-9, 1999 Jul-Aug.  [PUBMED Abstract]
   
   
8. Gershenwald JE, Thompson W, Mansfield PF, et al.: Multi-institutional melanoma lymphatic mapping experience: the prognostic value of sentinel lymph node status in 612 stage I or II melanoma patients. J Clin Oncol 17 (3): 976-83, 1999.  [PUBMED Abstract]
   
   
9. Mraz-Gernhard S, Sagebiel RW, Kashani-Sabet M, et al.: Prediction of sentinel lymph node micrometastasis by histological features in primary cutaneous malignant melanoma. Arch Dermatol 134 (8): 983-7, 1998.  [PUBMED Abstract]
   
   
10. Morton DL, Cochran AJ, Thompson JF, et al.: Sentinel node biopsy for early-stage melanoma: accuracy and morbidity in MSLT-I, an international multicenter trial. Ann Surg 242 (3): 302-11; discussion 311-3, 2005.  [PUBMED Abstract]
    
    

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